Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutide): Påverkan på kroppsvikt

Dulaglutide är inte indicerat för viktminskning. Dulaglutide 1,5 mg var associerat med viktminskning under hela varaktigheten av AWARD-studierna.

Detailed Information

In phase 3 studies, treatment with dulaglutide 1.5 mg was associated with sustained weight reduction from baseline over the duration of the studies including the longest study (AWARD-5, 104-week final endpoint) (Table 1. Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studies).1-10

The LSM change in BW from baseline to primary endpoint ranged from

  • -0.87 kg (AWARD-4) to -3.10 kg (AWARD-10) with dulaglutide 1.5 mg treatment, and

  • +0.20 kg (AWARD-1 , AWARD-4) to -2.60 kg (AWARD-5, AWARD-10) with dulaglutide 0.75 mg treatment.1-10

Table 1. Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studiesab

Primary Endpoint

DULA 1.5 mg

DULA 0.75 mg

Comparator

PBO

p Value

AWARD-31 – Comparator – MET

26 weeks

-2.29

-1.36

-2.22

N/A

p<.05 DULA 1.5 mg vs DULA 0.75 mg
p<.05 DULA 0.75 mg vs MET

AWARD-52,11– Comparator – SITA and PBO a
Background anti-diabetic medications: MET ≥ 1,500 mg/day

52 weeks

-3.03

-2.60

-1.53

-1.61

p<.001 both DULA vs SITA

AWARD-63 – Comparator – LIRA 
Background anti-diabetic medications: MET ≥ 1,500 mg/day

26 weeks

-2.90

N/A

-3.61

N/A

p=.011 DULA 1.5 mg vs LIRA

AWARD-84 – Comparator – PBO
Background anti-diabetic medications: GLIM

24 weeks

-0.91

N/A

N/A 

-0.24

p=.120 DULA 1.5 mg vs PBO

AWARD-15 – Comparator – EXE BID and PBOa
Background anti-diabetic medications: MET ≥ 1,500 mg/day and PIO 30-45 mg/day

26 weeks

-1.30

+0.20

-1.07

+1.24

p<.001 both DULA vs EXE
p<.001 DULA 1.5 mg vs DULA 0.75 mg

AWARD-106 – Comparator – PBO
Background anti-diabetic medications: SGLT-2 inhibitor
c with or without MET ≥ 1,500 mg/day

24 weeks

 -3.10

 -2.60

N/A

 -2.10

 p=.028 DULA 1.5 mg vs PBO
p=.26 DULA 0.75 mg vs PBO

AWARD-27– Comparator – GLAd
Background anti-diabetic medications: MET ≥ 1,500 mg/day and GLIM ≥ 4 mg/day

52 weeks

-1.87

-1.33

+1.44

N/A

p<.001  both DULA  vs GLA

AWARD-98 – Comparator – PBO
Background anti-diabetic medications: GLA
d with or without  MET ≥ 1,500 mg/day

28 weeks

-1.91

N/A

N/A

+0.50

p<.001 DULA 1.5 mg vs PBO

AWARD-49 – Comparator – GLAd
Background anti-diabetic medications: MET ≥ 1,500 mg/day and LIS
d

26 weeks

-0.87

+0.18

+2.33

N/A

p<.001 both DULA vs GLA

AWARD-710 – Comparator – GLAd
Background anti-diabetic medications: LIS
d

26 weeks

-2.81

-2.02

+1.11

N/A

p<.0001 both DULA  vs GLA

Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BID = twice daily; DULA = dulaglutide; EXE = exenatide; GLA = insulin glargine; GLIM = glimepiride; LIRA = liraglutide; LIS = insulin lispro; LSM = least squares mean; MET = metformin; N/A = not applicable; PBO = placebo; PIO= pioglitzaone; SGLT-2 = sodium-glucose contransporter-2; SITA = sitagliptin.

a LSM Changes in body weight from baseline to primary time point are not shown for placebo.

b Data presented as LSM kg

c canagliflozin, dapagliflozin, or empagliflozin

d titrated

References

1. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37(8):2168-2176. https://doi.org/10.2337/dc13-2759

2. Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761

3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. http://dx.doi.org/10.1016/S0140-6736(14)60976-4

4. Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634

5. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8):2159-2167. https://doi.org/10.2337/dc13-2760

6. Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381. https://doi.org/10.1016/S2213-8587(18)30023-8

7. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249. https://doi.org/10.2337/dc14-1625

8. Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937

9. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9

10. Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018;6(8):605-617. https://doi.org/10.1016/S2213-8587(18)30104-9

11. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

BW = body weight

LSM = least squares mean

Datum fӧr senaste ӧversyn 2018 M08 27

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